Senior Manufacturing Lead - Downstream
Company: FDBT - FUJIFILM Diosynth
Location: College Station
Posted on: January 14, 2021
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Job Description:
Overview Summary: The Senior Manufacturing Lead - Downstream
will lead a team and work directly with a range of purification
technologies including: filtration technologies (TFF and depth),
chromatographic separations (Single Use GE AKTA systems), viral
inactivation, etc. following aseptic techniques and procedures in a
cGMP environment. External US Essential Functions:* Responsible for
leading a team in the operation of chromatographic systems (Single
Use GE AKTA).* Responsible for coordinating daily manufacturing
floor activities.* Responsible for overseeing and preparing and
formulating buffers in accordance to procedures.* Responsible for
writing, reviewing, and/or updating Standard Operating Procedures
(SOPs) and Batch Production Records (BPRs).* Document and maintain
activity records according to cGMP regulations and ensure team
members are properly trained on all proper processes.* Coordinate
and implement project safety and quality assurance programs in
collaboration with senior staff and EH&S.* Ensure proper
documentation and execution of Batch Production Records for
assigned projects.* Maintain confidentiality of proprietary company
information.* Participate in and/or lead incident investigations.*
Maintain an effective working relationship with others.* Perform
all other duties as assigned.NCTM/Building 200 Essential
Functions:* Operation and familiarity with the following systems:*
Large-scale filtration systems including Tangential Flow Filtration
(TFF) and depth filtration.* Large-scale centrifugation systems
including Sucrose Density Centrifugation, Continuous Flow
Centrifugation, and Clarification.* Large-scale Chromatographic
systems (--KTA)* Lead team in continuous flow centrifugation,
sucrose gradient separation, various filtration technologies,
chromatographic separations technologies, and viral inactivation
following aseptic technique in a cGMP environment.* Provide input
and support to Process Development functions during development and
scale up activities as necessary.Building 100 Essential Functions:*
Ability to use and train employees with single use systems.*
Ability to operate and train employees on general production
equipment such as Incubators, Analytical Scales, pH/conductivity
meters, etc.* Lead team on ultrafiltration using single use
technology and aseptic final fill execution.Required Skills &
Abilities:* Excellent oral and written communication skills as well
as excellent interpersonal and organizational skills.* Demonstrated
leadership skills.* Ability to train others to perform and maintain
cGMP standards* Strong proficiency with Microsoft Office
applications.* Experience working in cleanroom environments.* Must
have flexible work hours, and be willing to work outside of normal,
scheduled hours, as necessary. Must be able to work alternative
shift hours and weekends as required.* Self-discipline and good
attention to detail.* Excellent math and computer skills.* Must
have exceptional planning skills and be willing to interface with
colleagues in many different roles and functions throughout the
manufacturing facilities and lead projects.Working Conditions &
Physical Requirements:The physical demands described here are
representative of those that must be met by an employee, in order
to successfully perform the essential functions of this job.
Reasonable accommodations may be made to enable individuals with
disabilities to perform essential functions. While performing the
duties of this job, the employee is required on a regular basis
to:* Experience prolonged standing, some bending, stooping, and
stretching.* Use hand-eye coordination and manual dexterity
sufficient to operate a keyboard, photocopier, telephone,
calculator, and other office equipment.* Ability to lift up to 25
pounds; frequently, and up to 50 pounds; on occasion.* Attendance
is mandatory.Qualifications:* Master's Degree preferably in
Biology, Microbiology, Chemistry, Biochemistry, Engineering or
related field with 3 years relevant experience of which 2 years
must be in a GMP environment; OR* Bachelor's Degree preferably in
Biology, Microbiology, Chemistry, Biochemistry, Engineering or
related field with 5 years relevant experience of which 2 years
must be in a GMP environment; OR* Associates Degree preferably in
Biology, Microbiology, Chemistry, Biochemistry, Engineering, or
related field with 7 years relevant experience of which 2 years
must be in a GMP environment.* High School Diploma or Associates
Degree preferably in Biology, Microbiology, Chemistry,
Biochemistry, Engineering, or related field with 9 years relevant
experience of which 2 years must be in a GMP environment.*
Experience with Mammalian Cell or Insect Cell, Yeast or Bacterial
Cell lines.Preferred Qualifications:* Six Sigma
CertificationSDL2017
Keywords: FDBT - FUJIFILM Diosynth, College Station , Senior Manufacturing Lead - Downstream, Other , College Station, Texas
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